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Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants

NCT00295230 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2007-11-07

No results posted yet for this study

Summary

Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. To date, only one recent study has investigated the relative advantages of combining VG with different modes of synchronized mechanical ventilation in clinically stable, preterm infants that were mechanically ventilated at an average age of one month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very low birth weight infants within the first three to five days of life. Our hypothesis is that in very low birth weight infants requiring mechanical ventilation in the first three to five days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average mean airway pressure in the PSV+VG group compared to the SIMV+VG group.

Conditions

  • Respiratory Distress Syndrome

Interventions

PROCEDURE

PSV+VG mode versus SIMV+VG mode

fully assisted mechanical ventilation versus assistance on only a select number of breaths

Sponsors & Collaborators

  • Windtree Therapeutics

    collaborator INDUSTRY

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Mark Mammel, MD · Children's Hospitals and Clinics of Minnesota

Eligibility

Min Age
72 Hours
Max Age
120 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295230 on ClinicalTrials.gov